Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New implant could help sleep apnea sufferers ditch CPAP

NCT ID NCT04031040

Disease control Sponsor: Nyxoah S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 110 adults with moderate to severe obstructive sleep apnea who have the Genio® device implanted. The device stimulates a nerve to keep the airway open during sleep. Researchers will track safety and effectiveness over 5 years, including changes in breathing pauses and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Genio® hypoglossal nerve stimulation device
What this could lead to
If successful, this could provide a long-term treatment option for people with moderate to severe sleep apnea who cannot use standard therapies like CPAP.
What could go wrong
This is a post-market study, so the device is already approved. However, it may not work for everyone, and risks include device-related side effects or the need for ongoing management.
Why investors are watching

Nyxoah is a very small company, so this 5-year post-market study of its Genio system for obstructive sleep apnea is a major test of whether the device works safely and effectively in adults with moderate to severe disease. The trial tracks 110 patients over five years after surgery, and the outcome will shape the company's credibility with doctors and patients.

If it works: A positive result could strengthen the case that Genio is a reliable long-term treatment for sleep apnea, which might help Nyxoah build its business and attract more attention from the medical community.

If it fails: If the study shows safety problems or weak effectiveness, or if it fails to complete, Nyxoah could lose trust and face a serious setback. Clinical trials often fail, so this outcome is uncertain.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Body Mass Index (BMI) \< 35 kg/m2 * AHI between 15 to 65 events/hour documented by the closest PSG performed at the time of the patient ICF signature and within maximum 12 months of screening and fulfilling the required technical criteria or during the screening phase. * Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments. Exclusion Criteria: * Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment; * Taking medication that in the opinion of the Investigator may alter consciousness, the pattern of respiration, or sleep architecture; * Major anatomical or functional abnormalities that would impair the ability of the Genio® system to treat OSA; * Inadequately treated psychiatric disease that prevent patient compliance with the requirements of the investigational study testing; * Life expectancy \< 12 months; * Participation in another clinical study (excluding registries) during the study period (3 years).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Obstructive sleep apnea are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstructive sleep apnea

Contacts and locations

Locations

  • Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie

    Hamburg, 21075, Germany

  • CEREVES Paris Jean Jaurès - Centre du sommeil

    Paris, 75019, France

  • CHU - Angers

    Angers, 49933, France

  • CHU Toulouse

    Toulouse, 31400, France

  • Clinique Beau-Soleil

    Montpellier, 34070, France

  • Clinique Mutualiste de la Sagesse

    Rennes, 35000, France

  • HNO-Klinik des Universitätsklinikums Jena

    Jena, 07747, Germany

  • Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie

    Wuppertal, 42283, Germany

  • Hôpital Bichat, Assistance Publique - Hôpitaux de Paris

    Paris, 75018, France

  • Hôpital Henri-Mondor AP-HP

    Créteil, 94010, France

  • Hôpital Privé La Louvière

    Lille, 59800, France

  • Hôpital Tenon AP-HP

    Paris, 75020, France

  • Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie

    Liestal, 4410, Switzerland

  • Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum

    Mannheim, 68167, Germany

  • Klinikum rechts der Isar der TU München

    München, 81675, Germany

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1061 AE, Netherlands

  • Polyclinique Saint Laurent

    Rennes, 35700, France

  • Universitair Ziekenhuis Antwerpen

    Antwerp, 2650, Belgium

  • Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn

    Antwerp, 2170, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.